中国药房2012，Vol.23Issue(38)：3597-3600,4.DOI:10.6039/j.issn.1001-0408.2012.38.16
2种利巴韦林制剂的人体生物等效性研究
Study on Bioequivalence of 2 Kinds of Ribavirin Preparations in Human Volunteers
蒋俊毅 1杨明威 1林慧 1钱薇 1耿燕 1周志群 1肖大伟1
作者信息
- 1. 南京大学医学院附属鼓楼医院药物Ⅰ期临床实验室,南京210008
- 折叠
摘要
Abstract
OBJECTIVE: To study bioequivalence of 2 kinds of ribavirin preparations. METHODS: In randomized crossover design, the plasma concentration of ribavirin in 20 healthy volunteers was determined by LC-MS after oral administration of Ribavirin effervescent tablet 150 mg (test preparation) and Ribavirin granules (reference preparation), and the major phannacokinetic parameters were calculated. RESULTS: The main phannacokinetic parameters of test preparation vs. Reference preparation were as follows: t1/2 (44.00±8.75 )h vs.(44.89± 10.44)h;tmax(1.0±0.7 ) h vs.(0.8±0.2) h;cmax(424.12± 133.03)ng·mL-1 vs.(406.09± 108.22)ng·mL-1; AUC0～108h(4 997.59 ± 1 322.31)ng·h·mL-1 vs.(4 921.16 ± 1 030.61 )ng·h·mL-1. The relative bioavailability of test tablet was (105.4 ± 37.4)% by AUC0～108h. The statistical result showed that there was no significant difference between 2 preparations in the t1/2, cmax, tmax, AUC0～108h. CONCLUSION: The method is specific, sensitive and accurate. The two preparations are bioequivalent.关键词
利巴韦林/生物等效性/药动学/液-质联用法/生物利用度Key words
Ribavirin/ Bioequivalence/ Pharmacokinetics/ LC-MS/ Bioavailability分类
医药卫生引用本文复制引用
蒋俊毅,杨明威,林慧,钱薇,耿燕,周志群,肖大伟..2种利巴韦林制剂的人体生物等效性研究[J].中国药房,2012,23(38):3597-3600,4.
